Associate Scientific Director Clinical Development - Endocrinology

Recordati • Bridgewater, NJ

4d • $144,000 - $198,000 • Onsite

About The Position

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.Reporting StructureReports To: Medical Director, Endocrinology, NADirect Reports: NoneAreas Managed: North America (U.S. and Canada)OverviewThe Associate Scientific Director, Endocrinology, NA (North America) is a key role in the delivery and support of many of the scientific activities required to support RRD’s Medical Strategy for the endocrinology franchise such as integrating Recordati’s scientific and clinical data into programs supporting medical affairs. They help interpret and communicate scientific topics, ensuring that scientific integrity and medical insights guide all their activities. They are involved in delivering almost all aspects of externally facing medical communications and serve as subject matter expert for other roles in medical affairs (MA).

Requirements

• MD degree is preferred, doctorate is required, with documented experience in endocrinology or metabolic diseases.
• Strong scientific background with at least five years of clinical experience.
• Pharmaceutical experience with a good knowledge of the applicable regulations is required.
• Proficiency in Microsoft Office suite, basic computer and typing skills, and tools/systems for managing clinical trials.
• Strong written and verbal English communication and presentation skills.
• Skilled at collaborating with stakeholders with varying viewpoints, influencing with and without authority, and negotiation. Includes relationship management of multiple stakeholders, internally and externally, such as KOLs, networks, PAGs (Patient Association Groups), CROs and others.

Nice To Haves

• Endocrinology and/or metabolism clinical development experience is strongly preferred.

Responsibilities

• Contributing to the Clinical Development plan, including identifying critical data gaps, defining evidence needs to support scientific objectives and key messages, and proposing data generation strategies that feed into the Scientific Data Evolution Plan.
• Supporting clinical trial protocol development as an endocrinology subject matter expert (SME), providing scientific and clinical guidance to ensure robust study design, methodological rigor, and alignment with clinical development objectives.
• Work collaboratively with evidence generation including clinical development and clinical operations on the design, execution, and interpretation of clinical trials in the endocrinology therapeutic area.
• Supporting clinical development regulatory interactions with the FDA, serving as the endocrinology SME providing scientific justification for study design, endpoints, and clinical rationale, and contributing to successful regulatory outcomes.
• Managing RRD’s Investigator Sponsored Studies (ISS) process, including tracking received applications, managing the review process, tracking the contracting process and conducting ongoing scientific communications with funded Principal Investigators (PIs).
• Working with PIs that have completed their ISS to provide, at the PIs request, scientific feedback on their outcomes communications and ensure dissemination of clinically relevant findings across the RRD organization.
• Supporting the overarching endocrinology medical and clinical strategy such as situation analyses, identification of evidence needs, and development of key scientific messages to support Clinical Development and cross‑functional alignment., all of which contribute to the tactical plans for the endocrinology franchise.

Benefits

• Annual bonus
• Health Insurance: Medical, dental, orthodontia, vision, life & ADD, short and long term disability insurance benefits.
• Retirement Benefits: 401k
• Paid Time Off: Vacation, holiday, and sick/personal time.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree